Does anyone have experience providing a summary of Pre-IDE discussions in the 510k

A

Aaria

#1
#1
Does anyone have experience providing a summary of Pre-IDE discussions in the 510k? I would be interested in hearing about the format, level of details etc. included in the submission.
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Stijloor

Stijloor

Staff member
Super Moderator
#2
#2
Re: Does anyone have experience providing a summary of Pre-IDE discussions in the 510

A Quick Bump!

Can someone help?

Thank you very much!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 3
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
A MDS software - Does anyone have experience with iPoint? RoHS, REACH, ELV, IMDS and Restricted Substances 8
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
J Does anyone have experience in submitting TSE Dossiers to EDQM? EU Medical Device Regulations 1
K Does anyone has experience with determining if Lubricants and Greases are Food Grade? Food Safety - ISO 22000, HACCP (21 CFR 120) 6
I Does anyone here have experience with ISO 3951? Other ISO and International Standards and European Regulations 3
B Does anyone here have any experience with the Deming Prize? Quality Tools, Improvement and Analysis 1
N Does anyone have any experience or feedback using mind mapping software? Quality Tools, Improvement and Analysis 5
D Does anyone have experience using open source software for PDM? ISO 13485:2016 - Medical Device Quality Management Systems 1
E Does anyone have experience with ProWorksinfo software for Work Instructions? Quality Assurance and Compliance Software Tools and Solutions 1
I Does anyone have direct experience with BVQI (Brazil)? Registrars and Notified Bodies 3
L Notified Body - Does anyone have experience using TUV Essex? Registrars and Notified Bodies 2
D Agile and Oracle - Does anyone have experience with Agile integrated with Oracle? Quality Tools, Improvement and Analysis 2
D Does anyone have any experience with NADCAP? Various Other Specifications, Standards, and related Requirements 15
D SMP - Skills Management Process - Does anyone else have experience with SMP? Training - Internal, External, Online and Distance Learning 4
A Does anyone have any experience in changing their certification body (registrar)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
J Gage R&R Software - Does anyone have experience using Mitutoyo's "MeasurLink"? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 11
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 5
B Does anyone charge for annual layouts? APQP and PPAP 8
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Does anyone have example test report of defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Definition Parallel Loop - Does anyone know what the term Parallel loop means? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Does Anyone utilize MS Outlook Read Receipts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Does anyone know what is going on in DQS? Registrars and Notified Bodies 1
P Scope Document - Does anyone happen to have an Example Scope Document (4.3)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7

Similar threads

Top Bottom